BIOVIE INC.
BIVI evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for BIVI—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · BIVI
BioVie Inc. is a development-stage biopharmaceutical company focused on advancing its lead candidate bezisterim for neurological indications, with no approved products or revenues and a going-concern warning.
Key risk: Going concern risk
BioSniper Score
Based on 4 of 6 signals
Market Cap
$18.3M
Cash Runway
—
Lead Asset
bezisterim (NE3107) (Phase 3)
Next Catalyst
Phase2_Topline · Sep 30, 2026Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 2 clinical trials · 1 catalyst for BIOVIE INC..
Similar companies
BioVie Inc. is a development-stage biopharmaceutical company focused on advancing its lead candidate bezisterim for neurological indications, with no approved products or revenues and a going-concern warning.
- Cash and equivalents of $9.0M as of 2026-06-30 [sec].
- Shareholders' equity of $19.0M as of 2026-06-30 [sec].
- Accumulated deficit of approximately $368.6M as of March 31, 2026 [sec].
- Net cash used in operations of approximately $14.9M for the nine months ended March 31, 2026 [sec].
- Lead candidate bezisterim (NE3107) is in a Phase 2 study for new onset Parkinson's disease, which commenced in April 2025 [sec_mda].
- The company has a going-concern qualification and substantial doubt about its ability to continue as a going concern [sec].
What works
- Bezisterim (NE3107) has shown preclinical and Phase 2 data suggesting promotoric activity and enhancement of levodopa activity in Parkinson's disease [sec_mda].
- The company received a clinical trial award of up to $13.1 million from the U.S. Department of Defense for its Long COVID program [sec_mda].
- The FDA permitted the company to proceed with a new Phase 2 study of bezisterim as a potential first-line therapy for new onset Parkinson's disease [sec_mda].
What to weigh
- The company has no products approved for commercial sale and has never generated any revenues [sec].
- Substantial doubt exists about the company's ability to continue as a going concern, and additional financing is required to fund R&D [sec].
- The company has an accumulated deficit of approximately $368.6M as of March 31, 2026, and expects continued losses [sec].
- The company is subject to securities class action litigation, which could have a material adverse effect on its business [sec].
From the filings
Quoted directly from source documents.
Going concern uncertainty
“These factors raise substantial doubt about our ability to continue as a going concern.”
SEC filings · July 17, 2026
No product revenues
“We have not generated any product revenues, and do not expect to generate any revenues until, and only if, we develop, and receive approval to sell our product candidates from the FDA and other regulatory authorities for our product candidates.”
SEC filings · July 17, 2026
Accumulated deficit
“the Company had working capital of approximately $15.2 million, cash and cash equivalents totaling approximately $13.1 million, stockholders' equity of approximately $15.6 million, and an accumulated deficit of approximately $368.6 million.”
SEC filings · July 17, 2026
Phase 2 study for Parkinson's disease
“the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset PD. In July 2024, the Company submitted the new protocol and received a response from the FDA which permitted the Company to proceed with the study. The trial commenced in April 2025.”
SEC MD&A · May 12, 2025
Catalyst timeline
- 2026-09-30 · Phase2_Topline · bezisterim — Phase 2 Readout: bezisterim — Top-line results from the Phase 2 study of bezisterim in new onset Parkinson's disease are expected.
Risks & what to watch (4)›
Key risks
- Going concern risk — Substantial doubt about ability to continue as a going concern; may be unable to raise further equity [sec].
- No revenue or approved products — No products approved for commercial sale; never generated revenues; may never achieve profitability [sec].
- Clinical and regulatory uncertainty — Failure to complete trials or prove safety/efficacy would materially harm business [sec].
- Litigation exposure — Subject to securities class action litigation; no reserves established for potential liabilities [sec].
What to watch
- Top-line data from the Phase 2 study of bezisterim in new onset Parkinson's disease, expected around September 30, 2026 [catalyst_timeline].
- Ability to raise additional capital to fund ongoing R&D and operations [sec].
- Progress and outcomes of the Long COVID program funded by the DOD award [sec_mda].
- Resolution of securities class action litigation and any impact on financial condition [sec].
Sources: SEC filings · SEC MD&A · Generated August 27, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.39
Lead: Phase 3
1 candidate
1 upcoming, next in ~31d
No insider transactions in the last 180 days
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
33
Total value held
$1.4M
| Holder | Shares | Value |
|---|---|---|
| diametric capital, lp | 370,000 | $518K |
| vanguard capital management llc | 168,134 | $235K |
| prelude capital management, llc | 92,063 | $129K |
| geode capital management, llc | 84,203 | $118K |
| morgan stanley | 75,221 | $105K |
| renaissance technologies llc | 67,918 | $95K |
| citadel advisors llc | 45,292 | $63K |
| vanguard fiduciary trust co | 37,557 | $53K |
| jane street group, llc | 22,791 | $32K |
| xtx topco ltd | 21,226 | $30K |
Showing top 10 of 33 institutional holders of BIOVIE INC.. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 2.4%
- Days to cover
- 2.5
- Shares short
- 177,085
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
BIVI short interestGovernance
Frequently asked questions
What is the AI investment thesis for BIOVIE INC.?
BioVie Inc. is a development-stage biopharmaceutical company focused on advancing its lead candidate bezisterim for neurological indications, with no approved products or revenues and a going-concern warning.
What is BIOVIE INC.'s lead drug candidate?
BIOVIE INC.'s most advanced tracked candidate is bezisterim (NE3107) (Phase 3) for Parkinsons Disease (PD); Long COVID.
What is BIOVIE INC.'s next catalyst?
BIOVIE INC.'s next tracked catalyst is a Phase2_Topline event — "Phase 2 Readout: bezisterim" — expected September 30, 2026.
Who is the CEO of BIOVIE INC.?
Mr. Cuong Viet Do M.B.A. is the chief executive officer of BIOVIE INC. (BIVI).
Where is BIOVIE INC. headquartered?
BIOVIE INC. (BIVI) is headquartered in Carson City, NV, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.